Perioperative Analgesia by ESP Catheter on Recipient for Liver Transplantation

NCT04584151 | Terminated DMC

• 1 other identifier: VINMEC LT REC
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

Enhanced recovery after surgery (ERAS) programs were developed by Prof Henrik Kehlet in Denmark to reduce the hospitalization and improve the surgical outcomes. In these programs pain relief by regional analgesia techniques are highly recommended to reduced as much as possible the opioids used with their side effects. This program was created for colo-rectal surgeries and extended to other surgeries. In Liver transplants different programs has been described top reduce the use of peri-operative opioids but no with the ESP Animal and molecular studies in chronic pain showed the activation of glial cells, Monocytes and lymphocite K similar to the reaction during severe septis with immune reaction and toll like receptor activation. Regional anaesthesia analgesia is blocking this activation of Tool Like Receptors (TLR4) One of the discharge criteria after liver transplantation is the equilibrium of plasmatic cyclosporin Our hypothesis is with regional analgesia to avoid any immune disorder due to pain and reach earlier the discharge criteria than with standard analgesia Improve the quality of recovery and reduce the hospitalization stay after liver transplantation

Conditions

Liver Transplant Disorder

Outcome Measures

Primary Outcomes (1)

• Length of stay in hospital

  Time to reach the criteria of hospital discharge after liver transplantation

  up to 30 day

Secondary Outcomes (2)

• Duration of stay in Intensive care Unit (ICU)

  up to 72 hours

• Quality of recovery: score

  up to 30 days

Study Arms (2)

standard of care

NO INTERVENTION

Peri operative analgesia by opioid

Continuous regiona analgesia

EXPERIMENTAL

Peri operative algesia by continuous bilateral ESP catheters

Procedure: regional analgesia

Interventions

regional analgesia PROCEDURE

Insertion of bilateral ESP catheters

Continuous regiona analgesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age clinical indication for liver transplantation agree to participate and signed consent

You may not qualify if:

• Use of chronic opioid contra indication to perform ESP cathters Diagnosis of a chronic pain condition except liver disease Psychiatric or depression disorder allergy to local anesthetics

Sponsors & Collaborators

• Vinmec Healthcare System: lead

Study Sites (2)

VinMec INternational hospital

Hanoi, 100000, Vietnam

Location

VinMec INternational hopspital

Hanoi, Vietnam

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled prospective trial

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 12, 2020
• Study Start: November 1, 2020
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)